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临床试验/NCT02777099
NCT02777099Unknown不适用

Impact of Remote Ischemic Postconditioning on Autonomic Function and Prognosis in Clients With Acute Ischemic Stroke

Guangzhou University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Heart Rate Variabilities

研究概览

简要总结

The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC) initiates autonomic nervous system response and affects the prognosis in patients with acute ischemic stroke.

详细描述

Remote ischemic postconditioning (RIPostC) has proven effective in reducing the ischemia-reperfusion injury. But the defensive mechanism of RIPostC still unclear. Stroke is frequently associated with autonomic dysfunction. Heart rate variability (HRV) represents the autonomic nervous system activity.This study aims to investigate whether RIPostC correlates with autonomic function and thus predicts prognosis of stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed as ischemic stroke according to the Chinese guideline of diagnosis and treatment of acute ischemic stroke 2010
  • •Age between 18 to 85 years old
  • •initial ischemic stroke within 14 days or less.
  • •National Institutes of Health Stroke Scale (NIHSS)score 0-15
  • •Modified Rankin Scale(mRS)score 1-4
  • •Informed consent

排除标准

  • •Intravenous or arterial thrombolysis, or revascularization
  • •Acute myocardial infarction,atrial fibrillation,arrhythmia,or cardiogenic cerebral embolism
  • •Systolic Blood Pressure(SBP)>200mmHg after medication treatment
  • •Plasma fibrinogen>7g/L
  • •Upper limb fracture or percutaneous injury
  • •Subclavian artery stenosis
  • •With severe cardiac,respiratory,hepatic,and renal dysfunction or malignant tumor
  • •Simultaneous participation in another interventional study

研究组 & 干预措施

RIPostC

Experimental

Receiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning

干预措施: remote ischemic postconditioning (Procedure)

sham RIPostC

Sham Comparator

Receiving sham RIPostC with pressure set at the patient's diastolic blood pressure.

Intervention:Procedure:Sham Remote Ischemic Postconditioning

干预措施: sham remote ischemic postconditioning (Procedure)

结局指标

主要结局

Heart Rate Variabilities

时间窗: at the time points of baseline and 7 and 30 days after treatments

Heart rate variability (HRV) is one of the most promising markers represent for autonomic function.We assess the changes from baseline heart rate variability to 7days and 30days.

次要结局

  • National Institutes of Health Stroke Scale(NIHSS)(at the time points of baseline and 7days after treatments.)
  • Modified Rankin scale(mRS)(at the time points of baseline and 7,30 and 90 days after treatments)
  • Barthel Index(BI)(at the time points of baseline and 7,30 and 90 days after treatments)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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